RecruitingNot ApplicableNCT06150950

REHAB Fontan Failure: A Trial of Cardiac Rehabilitation

RCT of the Effects of Cardiac reHABilitation (REHAB) Among Patients With Fontan Failure


Sponsor

Stanford University

Enrollment

50 participants

Start Date

May 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to compare the impact of cardiac rehabilitation on Fontan failure patients' exertional tolerance, frailty, and quality of life. 1. Among patients with Fontan failure, will cardiac rehabilitation increase average daily steps compared to usual care? 2. Among patients with Fontan failure, will cardiac rehabilitation improve exertional tolerance (as measured by cardiopulmonary exercise testing), frailty, and self-reported quality of life metrics compared to usual care?


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether cardiac rehabilitation (a structured exercise and education program) can benefit adults who have Fontan circulation failure — a serious complication that can occur in people who were born with a heart defect and had a surgical procedure called the Fontan operation. The study aims to see if cardiac rehab can improve heart function, quality of life, and exercise capacity in this population. **You may be eligible if...** - You are 18 years or older - You have had a Fontan operation (a surgery for congenital heart disease) and now have Fontan failure, defined as having at least one of: reduced heart pumping function (EF below 50%), protein-losing enteropathy, plastic bronchitis, chronic use of diuretics (prescribed by a specialist), or poor exercise capacity **You may NOT be eligible if...** - You depend on IV heart medications to maintain blood pressure (inotrope-dependent) - You have symptomatic arrhythmias that are not controlled - You are pregnant - You already participate in a cardiac rehab program or have a medical reason you cannot - You are planning a Fontan-related procedure within the next 3 months - Your baseline oxygen levels at rest are below 80% Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCardiac rehabilitation

Cardiac rehabilitation is a multifaceted, comprehensive therapeutic intervention of personalized, supervised exercise training that is beneficial and well-studied among patients with non-ACHD heart failure and has consistently been shown to improve QOL. Unfortunately, cardiac rehabilitation has been underutilized with an overall participation \<50% of eligible patients despite international guidelines advocating for more consistent deployment of cardiac rehabilitation. A major a barrier to cardiac rehabilitation is access, as CMS-mandates a physician be within 3 minutes of the rehabilitation facility to assure insurance reimbursement. This mandate limits isolated, outpatient cardiac rehabilitation programs, especially in rural communities.

OTHERUsual care

For participants randomized to the usual care (no cardiac rehabilitation group), cardiac rehabilitation will not be initiated between randomization and for up to 16 weeks following randomization. The study protocol controls only referral to cardiac rehabilitation. All other aspects of the cardiac care, such as titration of guideline directed medical therapy will be at the discretion of clinicians.


Locations(2)

Stanford University

Stanford, California, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT06150950


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